1. health and fitness
2. therapy

MISSISSIPPI LEGISLATURE
REGULAR SESSION 2015
By:
To: Public Health and
Welfare
Senator(s) Harkins, Collins, Hill
SENATE BILL NO. 2485
(As Sent to Governor)
1
2
3
4
5
6
AN ACT ENTITLED THE "RIGHT TO TRY ACT"; TO AUTHORIZE LICENSED
PHYSICIANS TO PRESCRIBE OR RECOMMEND CERTAIN INVESTIGATIONAL
DRUGS, BIOLOGICAL PRODUCTS OR DEVICES TO CERTAIN ELIGIBLE
TERMINALLY ILL PATIENTS; TO PROVIDE DEFINITIONS; TO AMEND SECTION
73-25-37, MISSISSIPPI CODE OF 1972, IN CONFORMITY; AND FOR RELATED
PURPOSES.
7
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MISSISSIPPI:
8
SECTION 1.
9
10
This section shall be known and may be cited
as the "Right to Try Act."
(2)
11
12
(1)
For purposes of this section:
(a)
"Eligible patient" means a person who meets all of
the following requirements:
13
(i)
14
will lead to the person's death;
15
(ii)
Has a terminal illness, or a disability that
Has considered all other treatment options
16
currently approved by the United States Food and Drug
17
Administration and all relevant clinical trials conducted in this
18
state;
S. B. No. 2485
15/SS02/R286SG
PAGE 1
*SS02/R286SG*
~ OFFICIAL ~
G1/2
19
(iii)
Has received a prescription or
20
recommendation from the person's physician for an investigational
21
drug, biological product or device;
22
(iv)
Has given written informed consent, which
23
shall be at least as comprehensive as the consent used in clinical
24
trials for the use of the investigational drug, biological product
25
or device or, if the patient is a minor or lacks the mental
26
capacity to provide informed consent, a parent or legal guardian
27
has given written informed consent on the patient's behalf; and
28
(v)
Has documentation from the person's physician
29
that the person has met all of the requirements of this
30
subsection.
31
(b)
"Investigational drug, biological product or
32
device" means a drug, biological product or device, any of which
33
are used to treat the patient's terminal illness, that has
34
successfully completed phase one of a clinical trial but has not
35
been approved for general use by the United States Food and Drug
36
Administration and remains under investigation in a clinical
37
trial.
38
substances.
The term shall not include Schedule I controlled
39
(c)
"Terminal illness" means a disease that without
40
life-sustaining procedures will result in death in the near future
41
or a state of permanent unconsciousness from which recovery is
42
unlikely.
S. B. No. 2485
15/SS02/R286SG
PAGE 2
*SS02/R286SG*
~ OFFICIAL ~
43
44
(d)
"Written informed consent" means a written document
that is:
45
(i)
Signed by the:
46
1.
Patient;
47
2.
Parent, if the patient is a minor;
48
3.
Legal guardian; or
49
4.
Patient advocate designated by the patient
50
under the Uniform Health-Care Decisions Act, Section 41-41-201 et
51
seq.; and
52
53
(ii)
Attested to by the patient's physician and a
witness and that, at a minimum, includes all of the following:
54
1.
An explanation of the currently approved
55
products and treatments for the disease or condition from which
56
the patient suffers;
57
2.
An attestation that the patient concurs
58
with his or her physician in believing that all currently approved
59
and conventionally recognized treatments are unlikely to prolong
60
the patient's life;
61
3.
Clear identification of the specific
62
proposed investigational drug, biological product or device that
63
the patient is seeking to use;
64
4.
A description of the potentially best and
65
worst outcomes of using the investigational drug, biological
66
product or device and a realistic description of the most likely
67
outcome.
The description shall include the possibility that new,
S. B. No. 2485
15/SS02/R286SG
PAGE 3
*SS02/R286SG*
~ OFFICIAL ~
68
unanticipated, different, or worse symptoms might result and that
69
death could be hastened by the proposed treatment.
70
description shall be based on the physician's knowledge of the
71
proposed treatment in conjunction with an awareness of the
72
patient's condition;
73
5.
The
A statement that the patient's health plan
74
or third-party administrator and provider are not obligated to pay
75
for any care or treatments consequent to the use of the
76
investigational drug, biological product or device, unless they
77
are specifically required to do so by law or contract;
78
6.
A statement that the patient's eligibility
79
for hospice care may be withdrawn if the patient begins curative
80
treatment with the investigational drug, biological product or
81
device and that care may be reinstated if this treatment ends and
82
the patient meets hospice eligibility requirements; and
83
7.
A statement that the patient understands
84
that he or she is liable for all expenses consequent to the use of
85
the investigational drug, biological product or device and that
86
this liability extends to the patient's estate, unless a contract
87
between the patient and the manufacturer of the drug, biological
88
product or device states otherwise.
89
(3)
A manufacturer of an investigational drug, biological
90
product or device may make available the manufacturer's
91
investigational drug, biological product or device to eligible
92
patients under this section.
S. B. No. 2485
15/SS02/R286SG
PAGE 4
This section does not require that a
*SS02/R286SG*
~ OFFICIAL ~
93
manufacturer make available an investigational drug, biological
94
product or device to an eligible patient.
95
(a)
A manufacturer may:
Provide an investigational drug, biological product
96
or device to an eligible patient without receiving compensation;
97
or
98
99
100
101
(b)
Require an eligible patient to pay the costs of or
associated with the manufacture of the investigational drug,
biological product or device.
(4)
This section does not require a health care insurer to
102
provide coverage for the cost of any investigational drug,
103
biological product or device.
104
provide coverage for an investigational drug, biological product
105
or device.
106
(5)
However, a health care insurer may
This section does not require the Mississippi Department
107
of Corrections or any other governmental agency to provide
108
coverage for the cost of any investigational drug, biological
109
product or device.
110
(6)
This section does not require a licensed hospital or
111
nursing home to provide new or additional services, unless
112
approved by the hospital or facility.
113
114
115
(7)
This section does not require a licensed physician to
offer any investigational drug, biological product or device.
(8)
Notwithstanding any other provision of law to the
116
contrary, no state agency or regulatory board shall revoke, fail
117
to renew, or take any other action against a physician's license
S. B. No. 2485
15/SS02/R286SG
PAGE 5
*SS02/R286SG*
~ OFFICIAL ~
118
under Section 73-25-1 et seq., Mississippi Code of 1972, or
119
against a pharmacist's license under Section 73-21-71 et seq.,
120
based solely on the physician's or pharmacist's recommendation to
121
an eligible patient regarding prescription for or treatment with
122
an investigational drug, biological product or device.
123
against a health care provider's Medicare certification based
124
solely on the health care provider's recommendation that a patient
125
have access to an investigational drug, biological product or
126
device is prohibited.
127
(9)
Action
If the clinical trial is closed due to lack of efficacy
128
or toxicity, the drug shall not be offered.
129
a drug, product or device taken by a patient outside of a clinical
130
trial, the pharmaceutical company or patient's physician shall
131
notify the patient of the information from the safety committee of
132
the clinical trial.
133
(10)
If notice is given on
Except in the case of gross negligence or willful
134
misconduct, any person who manufactures, imports, distributes,
135
prescribes, dispenses, compounds or administers an investigational
136
drug or device to an eligible patient with a terminal illness in
137
accordance with this section shall not be liable in any action
138
under state law for any loss, damage or injury arising out of,
139
relating to, or resulting from:
140
141
(a)
The design, development, clinical testing and
investigation, manufacturing, labeling, distribution, sale,
S. B. No. 2485
15/SS02/R286SG
PAGE 6
*SS02/R286SG*
~ OFFICIAL ~
142
purchase, donation, dispensing, compounding, prescription,
143
administration, or use of the drug or device; or
144
145
(b)
(11)
The safety or effectiveness of the drug or device.
If a provision of this section or its application to
146
any person or circumstance is held invalid, the invalidity does
147
not affect other provisions or applications of this section that
148
can be given effect without the invalid provision or application,
149
and to this end the provisions of this section are severable.
150
SECTION 2.
Section 73-25-37, Mississippi Code of 1972, is
151
amended as follows:
152
73-25-37.
(1)
No duly licensed, practicing physician,
153
physician assistant, dentist, registered nurse, licensed practical
154
nurse, certified registered emergency medical technician, or any
155
other person who, in good faith and in the exercise of reasonable
156
care, renders emergency care to any injured person at the scene of
157
an emergency, or in transporting the injured person to a point
158
where medical assistance can be reasonably expected, shall be
159
liable for any civil damages to the injured person as a result of
160
any acts committed in good faith and in the exercise of reasonable
161
care or omissions in good faith and in the exercise of reasonable
162
care by such persons in rendering the emergency care to the
163
injured person.
164
(2)
(a)
Any person who in good faith, with or without
165
compensation, renders emergency care or treatment by the use of an
166
Automated External Defibrillator (AED) in accordance with the
S. B. No. 2485
15/SS02/R286SG
PAGE 7
*SS02/R286SG*
~ OFFICIAL ~
167
provisions of Sections 41-60-31 through 41-60-35, as well as the
168
person responsible for the site where the AED is located if the
169
person has provided for compliance with the provisions of Sections
170
41-60-31 through 41-60-35, shall be immune from civil liability
171
for any personal injury as a result of that care or treatment, or
172
as a result of any act, or failure to act, in providing or
173
arranging further medical treatment, where the person acts as an
174
ordinary, reasonably prudent person would have acted under the
175
same or similar circumstances and the person's actions or failure
176
to act does not amount to willful or wanton misconduct or gross
177
negligence.
178
(b)
A person who has not complied with the provisions
179
of Sections 41-60-31 through 41-60-35, but who has access to an
180
AED and uses it in good faith in an emergency as an ordinary
181
prudent person would have done in the same or similar
182
circumstances, shall be immune from civil liability for any
183
personal injury as a result of an act or omission related to the
184
operation of or failure to operate an AED if the person's actions
185
or failure to act do not amount to willful or wanton misconduct or
186
gross negligence.
187
(3)
Any employee of a local public school district, a
188
private school, or parochial school, trained in the administration
189
of auto-injectable epinephrine, who provides, administers, or
190
assists in the administration of auto-injectable epinephrine, in
191
accordance with the provisions of Section 37-11-71, to a student
S. B. No. 2485
15/SS02/R286SG
PAGE 8
*SS02/R286SG*
~ OFFICIAL ~
192
believed in good faith to be having an anaphylactic reaction,
193
shall be immune from civil liability for any personal injury as a
194
result of that care or treatment if the employee's actions or
195
failure to act do not amount to willful or wanton misconduct or
196
gross negligence.
197
(4)
The immunity from civil liability for any personal
198
injury under subsection (2) of this section includes the licensed
199
physician who authorizes, directs or supervises the installation
200
or provision of AED equipment in or on any premises or conveyance
201
other than a medical facility, the owner of the premises where an
202
AED is used, the purchaser of the AED, a person who uses an AED
203
during an emergency for the purpose of attempting to save the life
204
of another person who is or who appears to be in cardiac arrest,
205
and the person who provides the CPR and AED training.
206
(5)
The immunity from civil liability for any personal
207
injury under subsection (3) of this section includes the licensed
208
physician who prescribes the auto-injectable epinephrine, the
209
school district, or any other entity, that legally obtained the
210
auto-injectable epinephrine, and the person who provides the
211
training in the administration of auto-injectable epinephrine.
212
(6)
The immunity from civil liability under subsection (2)
213
and subsection (3) of this section does not apply if the personal
214
injury results from the gross negligence or willful or wanton
215
misconduct of the person rendering the emergency care.
S. B. No. 2485
15/SS02/R286SG
PAGE 9
*SS02/R286SG*
~ OFFICIAL ~
216
(7)
Except in cases of gross negligence or willful
217
misconduct, civil immunity shall apply to any licensed physician
218
or licensed pharmacist who prescribes or makes recommendation to
219
an eligible patient regarding prescription for or treatment with
220
an investigational drug, biological product or device under the
221
provisions of Section 1 of this act, and the State Board of
222
Medical Licensure and/or the State Board of Pharmacy, as the case
223
may be, shall be prohibited from taking any adverse action against
224
the license of such physician or pharmacist based solely on the
225
physician's action under the provisions of Section 1 of this act.
226
227
SECTION 3.
This act shall take effect and be in force from
and after July 1, 2015.
S. B. No. 2485
15/SS02/R286SG
PAGE 10
~ OFFICIAL ~
ST: Investigational drugs; authorize physicians
to prescribe to certain eligible terminally ill
patients.
*SS02/R286SG*